- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01705548
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week.
OUTLINE: This is a dose-escalation study.
Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks.
After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, United States, 30342
- Emory Saint Joseph's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pathologic proven diagnosis of solid tumor malignancy
- One brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.)
- Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) ≥ 70%
Exclusion Criteria:
- Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target volume would have received more than 12 Gy
- RPA class III (KPS < 70%)
- Brain metastasis or resection cavity volume < 3 cm or > 6 cm
- Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)
- Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or cerebrospinal fluid (CSF) cytology
- Current pregnancy
- More than 8 weeks between resection and radiosurgical procedure
- Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic apparatus (optic nerves and chiasm)
- Inability to undergo MRI evaluation for treatment planning and follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypofractionated Radiosurgery
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm. Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment. |
Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) of hypofractionated radiosurgery defined as the highest dose level where a grade 3 or greater with an attribution score of ≥ 3 develops in ≤ 2 of 6 patients in a dose group
Time Frame: 4 months
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Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
The rate of toxicities will be calculated with 95% confidence interval (CI).
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4 months
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Neurologic toxicity due to treatment, graded according to the CTCAE version 4.03
Time Frame: Up to 2 years
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Calculated with 95% CI.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local control; lack of progression of disease in resection cavity as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Time Frame: 4 months
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The median time to local brain progression will be calculated by Kaplan-Meier method with 95% CI.
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4 months
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Distant control: lack of progression of disease in surrounding brain as defined by RECIST criteria
Time Frame: 4 months
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The median time to distant brain progression will be calculated by Kaplan-Meier method with 95% CI.
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4 months
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Freedom from failure/progression free survival
Time Frame: Up to 2 years
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Up to 2 years
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Overall survival (OS): death from any cause
Time Frame: Up to 2 years
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The median of OS time with 95% CI will be calculated by Kaplan-Meier method.
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Up to 2 years
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Long-term neurocognitive outcomes: using the Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam (MMSE) and Cognitive Functioning Subscale of the Medical Outcomes Scale (MOS)
Time Frame: Up to 2 years
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Neurocognitive effect will be regressed over time using generalized estimating equation (GEE) model.
The population change over time (slope) will be estimated with 95% CI.
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Up to 2 years
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Quality of life (QOL) outcomes: using the quality of life questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).
Time Frame: Up to 2 years
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QOL outcomes will be regressed over time using GEE model.
The population change over time (slope) will be estimated with 95% CI.
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Up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bree Eaton, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00055063
- P30CA138292 (U.S. NIH Grant/Contract)
- NCI-2012-01933 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- RAD2156-11 (Other Identifier: Winship Cancer Institute)
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